The National Health Service (Miscellaneous Amendments Relating to Community Pharmaceutical Services and Optometrist Prescribing) Regulations 2009

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations further amend the National Health Service (General Medical Services Contracts) Regulations 2004 (“the GMS Regulations”), the National Health Service (Personal Medical Services Agreements) Regulations 2004 (“the PMS Regulations”), the National Health Service (Pharmaceutical Services) Regulations 2005 (“the PS Regulations”) and the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 (“the LPS Regulations”). The amendments relate to the statutory arrangements governing the provision of NHS community pharmaceutical services and optometrist prescribing.

Regulations 3(a)(i), 9 and 12 remove from the PS Regulations references to Community Health Councils, which have been abolished, and replace those references where appropriate with references to Local Improvement Networks.

Regulations 3(a)(ii) to (iv), 30, 35 and 36 contain measures which amend the PS Regulations, the LPS Regulations, the GMS Regulations and the PMS Regulations to allow retail pharmacies and dispensing doctors that are entitled to dispense against NHS prescriptions to dispense against prescriptions issued by an optometrist who is qualified to order drugs, medicines and appliances as an optometrist independent prescriber.

Regulations 3(b), 4, 14, 15, 16, 19, 23, 25, 31, 33 and 34(3) contain measures enabling temporary emergency changes to the arrangements for the provision of pharmaceutical services and local pharmaceutical services in England in the event of an emergency arising out of a threat to human welfare which is caused or which may be caused by human illness (for example, pandemic influenza). In the case of such an emergency, arrangements are put in place to enable retail pharmacies and dispensing doctors to relocate temporarily or take on additional premises without needing to go through the normal applications process – and to enable dispensing doctors to provide pharmaceutical services to patients who are not on their normal patient list. Retail pharmacies included in a pharmaceutical list, whose opening hours are subject to detailed provisions in the PS Regulations, are given additional flexibilities to allow them to make emergency changes to their opening hours and to close premises, where it is reasonable to do so. Retail pharmacies and dispensing doctors will revert to their normal arrangements with their Primary Care Trust after the emergency, unless these have been changed in the mean time via the normal applications process.

Regulations 5, 6 and 28 replace the word “desirable” with the word “expedient” in a number of places in the PS Regulations. This is to reflect the replacement of the word “desirable” with the word “expedient” in the enabling primary legislation.

Regulations 7, 8, 10 and 11 make minor changes to the applications process relating to the lists of providers of pharmaceutical services kept by Primary Care Trusts. These changes amend the notification requirements in relation to applications, change some of the information to be provided, and prevent Primary Care Trusts from granting applications from retail pharmacies to open up adjoining premises as new premises, unless they are satisfied that it would be unreasonable to treat the two premises as one site.

Regulation 13 contains new arrangements for dealing with change of ownership applications in respect of pharmacy premises where the pharmacist who is currently entitled to provide pharmaceutical services from those premises is subject to an investigation by the relevant Primary Care Trust. Essentially, it becomes possible to grant the change of ownership application but continue with the proceedings against the pharmacist, even if the pharmacist no longer has any premises in the Primary Care Trust’s area.

Regulations 17 and 18 amend the PS Regulations to clarify the circumstances in which retail pharmacists on a pharmaceutical list may vary their opening hours without the prior authorisation of their Primary Care Trust – and the circumstances in which an application for a change of opening hours may be made in respect of a pharmacy which must be open for at least 100 hours per week. Also, Easter Sunday is added to the list of days on which a pharmacy is deemed to have been open for the purpose of calculating a pharmacy’s opening hours – and regulation 24 also makes this computation change in respect of the opening hours of dispensing appliance contractors.

Regulations 20 and 34(2) amend the PS Regulations and the LPS Regulations to extend the scope of the restrictions on a retail pharmacist – and the people working for them – providing inducements to customers in consideration for receiving services from the pharmacist. The restrictions now also cover additional services such as the provision of healthy eating advice or smoking cessation advice. However, there are exceptions allowing pharmacists to provide a low value gift to a patient if certain specified conditions are met. Pharmacists are also now prohibited from providing inducements to NHS bodies, or people employed or engaged by them, for them to recommend the pharmacist to potential customers.

Regulations 21, 22, 26 and 27 amend the PS Regulations to provide that where a pharmacist or appliance dispensing contractor which is a body corporate appoints a new superintendent or director, it must supply certain details in respect of that person to the relevant Primary Care Trust.

Regulation 32 amends the LPS Regulations to extend the information sharing obligations of Primary Care Trusts where they have concerns relating to their current and former contractors. In certain circumstances, they are under a duty to inform other Primary Care Trusts and the Royal Pharmaceutical Society of Great Britain of their concerns.